Abstract
Introduction:AIRWAYS-2 was a cluster randomised controlled trial (RCT) comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (OHCA). In order to successfully conduct this clinical trial, it was necessary for research paramedics to overcome multiple challenges, many of which will be relevant to future emergency medical service (EMS) research. This article aims to describe a number of the challenges that were encountered during the out-of-hospital phase of the AIRWAYS-2 trial and how these were overcome.Methods:The research paramedics responsible for conducting the pre-hospital phase of the trial were asked to reflect on their experience of facilitating the AIRWAYS-2 trial. Responses were then collated by the lead author. A process of iterative revision and review was undertaken by the research paramedics to produce a consensus of opinion.Results:The main challenges identified by the trial research paramedics related to the recruitment and training of paramedics, screening of eligible patients and investigation of protocol deviations / reporting errors. Even though a feasibility study was conducted prior to the commencement of AIRWAYS-2, the scale of these challenges was underestimated.Conclusion:Large-scale pragmatic cluster randomised trials are being successfully undertaken in out-of-hospital care. However, they require intensive engagement with EMS clinicians and local research paramedics, particularly when the intervention is contentious. Feasibility studies are an important part of research but may fail to identify all potential challenges. Therefore, flexibility is required to manage unforeseen difficulties.
Highlights
AIRWAYS-2 was a cluster randomised controlled trial (RCT) comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (OHCA)
In order to successfully conduct this clinical trial, it was necessary for the research paramedics (RPs), who were responsible for paramedic recruitment and training, patient screening and data collection, to overcome multiple challenges, many of which will be relevant to future emergency medical service (EMS) research
This paper aims to describe a number of the challenges that were encountered by the research paramedics during the delivery of the pre-hospital phase of the AIRWAYS-2 trial and how these were overcome
Summary
In order to successfully conduct this clinical trial, it was necessary for research paramedics to overcome multiple challenges, many of which will be relevant to future emergency medical service (EMS) research. AIRWAYS-2 was a cluster randomised controlled trial (RCT) comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (OHCA). It is the largest trial of its kind published to date, and the results have advanced the evidence base for an important area of emergency medical service (EMS) practice (Benger et al 2018). In keeping with good research practice, a feasibility study was conducted (REVIVE-Airways) prior to the main study (Benger et al 2016), with paramedics involved in the development of the feasibility and main study (Benger et al 2013; Rhys et al 2013; Taylor et al 2016)
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